Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338832
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2006-06-16
Brief Title:
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Sponsor:
Veterans Medical Research Foundation
Organization:
Veterans Medical Research Foundation
Study Overview
Official Title:
Adapting a Physical Activity Intervention for Schizophrenia
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of a lifestyle intervention in increasing physical activity and reducing disease symptoms in sedentary adults with schizophrenia
Detailed Description:
Schizophrenia is a severely disabling brain disorder People with schizophrenia often experience hallucinations delusions thought disorders and movement disorders Physical activity PA has been shown not only to increase quality of life but also to reduce risk factors for several chronic diseases and conditions The majority of adults however do not engage in the recommended amount of PA Research has shown that people with schizophrenia are even less likely to be regularly physically active Symptoms of schizophrenia pharmacological treatments for the disease and the lifestyle associated with the disease tend to contribute to physical inactivity and the resulting complications Effective interventions to increase PA have been developed for the general adult population but very little is known about how to adapt them for use in adults with schizophrenia The PRIME Physically Ready for Invigorating Movement Every Day program is a lifestyle intervention focused on increasing physical activity This study will evaluate the effectiveness of a modified PRIME program in reducing the risk for morbidity in sedentary adults with schizophrenia
Participants in this 24-week single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group which will involve the Program for Activity Leisure Skills and Socialization PALSS All participants will attend 90-minute sessions weekly for the first 16 weeks then biweekly for the remaining 8 weeks PRIME sessions will focus on learning about PA setting PA-related goals and assessing short- and long-term goals Goals may include early-stage process-oriented goals such as reading about PA benefits or finding a walking partner Goals tailored to later stages of change include explicit PA goals such as increasing frequency duration and intensity of PA Training will also be accomplished online and via printed material PALSS sessions will focus on motivating participants to engage in leisure and social activity Sessions will include interactive structured activity that will be led by a therapist as well as unstructured leisure activities such as board games cards general socialization and viewing a travel video Social and communication skills will not be explicitly taught or practiced All participants will attend study visits at Months 2 6 and 8 to assess outcomes A follow-up visit will be held 2 months post-intervention
Participants in this 24-week single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group which will involve the Program for Activity Leisure Skills and Socialization PALSS All participants will attend 90-minute sessions weekly for the first 16 weeks then biweekly for the remaining 8 weeks PRIME sessions will focus on learning about PA setting PA-related goals and assessing short- and long-term goals Goals may include early-stage process-oriented goals such as reading about PA benefits or finding a walking partner Goals tailored to later stages of change include explicit PA goals such as increasing frequency duration and intensity of PA Training will also be accomplished online and via printed material PALSS sessions will focus on motivating participants to engage in leisure and social activity Sessions will include interactive structured activity that will be led by a therapist as well as unstructured leisure activities such as board games cards general socialization and viewing a travel video Social and communication skills will not be explicitly taught or practiced All participants will attend study visits at Months 2 6 and 8 to assess outcomes A follow-up visit will be held 2 months post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH071539 | NIH | None | None |
| DAHBR 96-BHB | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH071539 |